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NCT03259308 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis

A Phase 3 study, sponsored by Shire.

Terminated
Registry status
Phase 3
Development phase
279
Enrollment target

NCT03259308 is a Phase 3 study that was terminated before completion, run by Shire. The registered enrollment target is 279 participants.

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The verdict

NCT03259308, a Phase 3 study, was terminated before completion, sponsored by Shire.

TERMINATED
Registry status
Phase 3
Development phase
279 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

Interventions

  • DRUG Placebo
  • DRUG Ontamalimab

Trial Details

FieldValue
Enrollment Target 279 participants
Start Date 2017-12-05
Est. Completion 2020-10-06
Phase Phase 3

Sponsor

Shire

245 total trials

What the Registry Record Tells You About NCT03259308

The ClinicalTrials.gov registry entry for NCT03259308 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 279 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03259308 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03259308 about?

NCT03259308 is a clinical study titled "Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis". The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

What is the current status of trial NCT03259308?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 279 participants. The study started on 2017-12-05. Estimated completion is 2020-10-06.

What interventions are being tested in trial NCT03259308?

The interventions under investigation include: Placebo (DRUG), Ontamalimab (DRUG).

Who is sponsoring clinical trial NCT03259308?

This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.